Bisphenol A: Europe and the United States take regulatory measures to limit its use

20/1/2017

BPA added to the Candidate List and to Annex XVII of the REACH Regulation

Bisphenol A has been officially added to the Candidate list and to the Annex XVII since the 12th December 2016. This major change of regulatory status follows the opinion adopted in 2014 by the Risk Assessment Committee of ECHA toward a more stringent classification. This opinion was based on the effects of the substance on female reproductive capacity and on female and male reproductive organs, documented in the Annex XV dossier that France submitted to ECHA.

Moreover, the dossier indicated a risk for workers (primarily cashiers) and consumers exposed to bisphenol A (BPA) by handling thermal paper receipts and proposed a restriction on the placing on the market. It was found that BPA constitutes a risk to the unborn children of pregnant workers as well as for consumers exposed to BPA contained in the thermal paper they handle.

Indeed, thermal paper is composed of a base paper with at least one coating layer which often contains BPA. The coating changes colour when exposed to heat, allowing the printed characters to appear.

France based its hazard assessment of BPA on the effects on several human health endpoints (female reproductive system, brain and behaviour, mammary gland, metabolism and obesity). The effects on the mammary gland were considered as the most critical endpoint, prevailing over the others.

ECHA�s final conclusion is that BPA shall not be placed on the market in thermal paper in a concentration equal to or greater than 0.02% by weight after 2 January 2020.

California agency launches a new database of BPA-containing products

Meanwhile, California's Office of Environmental Health Hazard Assessment (Oehha) has launched a database of bisphenol A-containing products on its public Proposition 65 website.

This new database has not been welcomed by many industry groups that continue to advocate the safety of BPA in food packaging.

Warning for exposure to BPA has been required to be displayed since 11 May 2016. But using a series of emergency and temporary rules, Oehha has allowed canned and bottled food and drink products to comply through uniform point-of-sale signs, in lieu of traditional on-product labels. The rule's latest iteration extended the compliance option to 30 December 2017.

A coalition of NGOs said it was unreasonable for the agency to expect customers wanting to avoid BPA to have to search an online database while standing in line at a grocery store.

Despite the criticism, the agency included the website reporting provision in its final rule. The database contains nearly 20,000 entries. It includes such details as a product's brand and description, size, universal product code (UPC) and category. It also includes a date column allowing manufacturers transitioning to BPA alternatives to indicate the 'use by' date beyond which products have been manufactured without BPA.

What substitutes to BPA?

The French Ministry in charge of the Environment and the INERIS (French public research body of an industrial and commercial character) launched a national helpdesk that provides operational support on technical and technological matters, to economic operators engaged in chemicals substitution.

The website created by INERIS delivers information regarding bisphenols and phthalates. In addition to this website, a national guidance document helping with the substitution of endocrine disrupters is expected to be published in 2017.

Would you like to know more on this topic?

Do not hesitate to check Chemical's Watch related article and ECHA�s website as well as our page on the traceability of substances. You can also reach our experts by calling +33 (0)1 83 64 20 54 for Europe or +1 (778) 231 1607 for North America or by email contact@ecomundo.eu if you have any questions!

BPA added to the Candidate List and to Annex XVII of the REACH Regulation

Bisphenol A has been officially added to the Candidate list and to the Annex XVII since the 12th December 2016. This major change of regulatory status follows the opinion adopted in 2014 by the Risk Assessment Committee of ECHA toward a more stringent classification. This opinion was based on the effects of the substance on female reproductive capacity and on female and male reproductive organs, documented in the Annex XV dossier that France submitted to ECHA.

Moreover, the dossier indicated a risk for workers (primarily cashiers) and consumers exposed to bisphenol A (BPA) by handling thermal paper receipts and proposed a restriction on the placing on the market. It was found that BPA constitutes a risk to the unborn children of pregnant workers as well as for consumers exposed to BPA contained in the thermal paper they handle.

Indeed, thermal paper is composed of a base paper with at least one coating layer which often contains BPA. The coating changes colour when exposed to heat, allowing the printed characters to appear.

France based its hazard assessment of BPA on the effects on several human health endpoints (female reproductive system, brain and behaviour, mammary gland, metabolism and obesity). The effects on the mammary gland were considered as the most critical endpoint, prevailing over the others.

ECHA�s final conclusion is that BPA shall not be placed on the market in thermal paper in a concentration equal to or greater than 0.02% by weight after 2 January 2020.

California agency launches a new database of BPA-containing products

Meanwhile, California's Office of Environmental Health Hazard Assessment (Oehha) has launched a database of bisphenol A-containing products on its public Proposition 65 website.

This new database has not been welcomed by many industry groups that continue to advocate the safety of BPA in food packaging.

Warning for exposure to BPA has been required to be displayed since 11 May 2016. But using a series of emergency and temporary rules, Oehha has allowed canned and bottled food and drink products to comply through uniform point-of-sale signs, in lieu of traditional on-product labels. The rule's latest iteration extended the compliance option to 30 December 2017.

A coalition of NGOs said it was unreasonable for the agency to expect customers wanting to avoid BPA to have to search an online database while standing in line at a grocery store.

Despite the criticism, the agency included the website reporting provision in its final rule. The database contains nearly 20,000 entries. It includes such details as a product's brand and description, size, universal product code (UPC) and category. It also includes a date column allowing manufacturers transitioning to BPA alternatives to indicate the 'use by' date beyond which products have been manufactured without BPA.

What substitutes to BPA?

The French Ministry in charge of the Environment and the INERIS (French public research body of an industrial and commercial character) launched a national helpdesk that provides operational support on technical and technological matters, to economic operators engaged in chemicals substitution.

The website created by INERIS delivers information regarding bisphenols and phthalates. In addition to this website, a national guidance document helping with the substitution of endocrine disrupters is expected to be published in 2017.

Would you like to know more on this topic?

Do not hesitate to check Chemical's Watch related article and ECHA�s website as well as our page on the traceability of substances. You can also reach our experts by calling +33 (0)1 83 64 20 54 for Europe or +1 (778) 231 1607 for North America or by email contact@ecomundo.eu if you have any questions!